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Document 32023R1719
Commission Regulation (EU) 2023/1719 of 8 September 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, metaldehyde, Metarhizium brunneum strain Ma 43, paclobutrazol and Straight Chain Lepidopteran Pheromones (SCLP) in or on certain products (Text with EEA relevance)
Commission Regulation (EU) 2023/1719 of 8 September 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, metaldehyde, Metarhizium brunneum strain Ma 43, paclobutrazol and Straight Chain Lepidopteran Pheromones (SCLP) in or on certain products (Text with EEA relevance)
Commission Regulation (EU) 2023/1719 of 8 September 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, metaldehyde, Metarhizium brunneum strain Ma 43, paclobutrazol and Straight Chain Lepidopteran Pheromones (SCLP) in or on certain products (Text with EEA relevance)
C/2023/6009
OJ L 223, 11.9.2023, p. 9–25
(BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
In force
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11.9.2023 |
EN |
Official Journal of the European Union |
L 223/9 |
COMMISSION REGULATION (EU) 2023/1719
of 8 September 2023
amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, metaldehyde, Metarhizium brunneum strain Ma 43, paclobutrazol and Straight Chain Lepidopteran Pheromones (SCLP) in or on certain products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (1), and in particular Article 5 and Article 14(1), point (a), thereof,
Whereas:
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(1) |
For isoxaben, metaldehyde and paclobutrazol, maximum residue levels (‘MRLs’) were set in Annex II to Regulation (EC) No 396/2005. For Metarhizium brunneum strain Ma 43 and Straight Chain Lepidopteran Pheromones (SCLP), no specific MRLs were set, nor were those substances included in Annex IV to that Regulation, so the default value laid down in Article 18(1), point (b), thereof applies. |
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(2) |
As regards metaldehyde, an application pursuant to Article 6(1) of Regulation (EC) No 396/2005 requesting a modification of the existing MRLs was submitted for flowering brassica and leafy brassica. |
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(3) |
In addition, in the framework of another application pursuant to Article 6(1) of Regulation (EC) No 396/2005, another applicant had submitted information previously unavailable during the review conducted in accordance with Article 12 of Regulation (EC) No 396/2005 on a hydrolysis study investigating the effect of sterilisation on the nature of residue. This study demonstrated that the existing MRLs for metaldehyde in potatoes, other root and tuber vegetables except sugar beets (except swedes/rutabagas), tomatoes, aubergines/eggplants, brassica vegetables (excluding brassica roots and brassica baby leaf crops), lettuces and salad plants, spinaches and similar leaves, globe artichokes are fully supported by data. |
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(4) |
As regards paclobutrazol, an applicant submitted information previously unavailable during the review conducted in accordance with Article 12 of Regulation (EC) No 396/2005 on a representative study investigating primary crop metabolism in fruit crops. This study demonstrated that the existing MRLs for that substance in apples, pears, quinces, medlars, loquats/Japanese medlars, apricots and peaches are fully supported by data. |
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(5) |
In accordance with Article 8 of Regulation (EC) No 396/2005, all those applications were evaluated by the Member States concerned and the evaluation reports were forwarded to the Commission and to the European Food Safety Authority (‘the Authority’). |
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(6) |
The Authority assessed the applications and the evaluation reports, examining in particular the risks to consumers and, where relevant, to animals, and gave reasoned opinions on the proposed MRLs (2). It forwarded those opinions to the applicants, the Commission and the Member States and made them available to the public. |
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(7) |
The Authority concluded that all requirements with respect to completeness of data submission were met and that the modifications to the MRLs requested by the applicants were acceptable with regard to consumer safety on the basis of a consumer exposure assessment for 27 specific European consumer groups. In so concluding, the Authority took into account the most recent data on the toxicological properties of the substances. Neither the long-term exposure to these substances via consumption of all food products that may contain them, nor the short-term exposure due to high consumption of the relevant products showed a risk that the acceptable daily intake or the acute reference dose is exceeded. |
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(8) |
As regards isoxaben, an application requesting a modification of the existing MRL for isoxaben in gherkins was submitted pursuant to Article 6(1) of Regulation (EC) No 396/2005. |
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(9) |
For that application, a Member State made a request to use the fast-track procedure, provided for in the Technical Guidelines on the MRL setting procedure (3), to set an MRL based on residue trials on courgettes. |
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(10) |
The Authority has assessed residue trials on courgettes in the framework of the review of the existing MRLs for isoxaben and given a reasoned opinion on the proposed MRL (4). That opinion relies on the current scientific and technical knowledge on the subject. As it is appropriate to extrapolate from the residue trials on courgettes to gherkins, as confirmed by the Union guidelines on extrapolation of MRLs (5), it is unnecessary to request the Authority to provide a reasoned opinion on gherkins specifically. |
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(11) |
It is therefore appropriate to set the MRL for isoxaben in gherkins at 0,05 mg/kg on the basis of the residue trials performed on courgettes. |
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(12) |
Metarhizium brunneum strain Ma 43 and Straight Chain Lepidopteran Pheromones (SCLP) have been renewed as low-risk active substances by Commission Implementing Regulations (EU) 2022/383 (6) and (EU) 2022/1251 (7), respectively. The conditions of use of those substances are not expected to lead to the presence of residues in food or feed commodities that may pose a risk to the consumer and, therefore, no MRLs are required. It is therefore appropriate to include those substances in Annex IV to Regulation (EC) No 396/2005. |
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(13) |
Based on the reasoned opinions of the Authority and taking into account the relevant factors listed in Article 14(2) of Regulation (EC) No 396/2005, the proposed modifications to the MRLs fulfil the requirements of Article 14(2) of that Regulation. |
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(14) |
Regulation (EC) No 396/2005 should therefore be amended accordingly. |
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(15) |
For technical reasons, the amendments to the proposed MRLs should apply later than those of Commission Regulation (EU) 2023/466 (8). |
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(16) |
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, |
HAS ADOPTED THIS REGULATION:
Article 1
Annexes II and IV to Regulation (EC) No 396/2005 are amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
It shall apply from 27 September 2023.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 8 September 2023.
For the Commission
The President
Ursula VON DER LEYEN
(2) European Food Safety Authority. Reasoned Opinion on the modification of the existing maximum residue levels for metaldehyde in flowering brassica and leafy brassica. EFSA Journal 2023;21(3):7885.
European Food Safety Authority. Reasoned opinion on the modification of the existing MRLs for metaldehyde in certain legume vegetables and pulses. EFSA Journal 2014;12(1):3537.
European Food Safety Authority. Reasoned Opinion on the evaluation of confirmatory data following the Article 12 MRL review for paclobutrazol. EFSA Journal 2022;20(11):7651.
(3) Technical guidelines MRL setting procedure in accordance with Articles 6 to 11 of Regulation (EC) No 396/2005 and Article 8 of Regulation (EC) No 1107/2009 (SANTE/2015/10595 Rev. 6.1).
(4) European Food Safety Authority. Reasoned opinion on the review of the existing maximum residue levels for isoxaben according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2022;20(1):7062.
(5) Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolation of residue data on products from plant and animal origin (SANTE/2019/12752 – 23 November 2020).
(6) Commission Implementing Regulation (EU) 2022/383 of 4 March 2022 renewing the approval of the low-risk active substance Metarhizium brunneum strain Ma 43 (formerly Metarhizium anisopliae var. anisopliae strain BIPESCO 5/F52) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 76, 7.3.2022, p. 1).
(7) Commission Implementing Regulation (EU) 2022/1251 of 19 July 2022 renewing the approval of the active substances Straight Chain Lepidopteran Pheromones (acetates) as low-risk active substances, and Straight Chain Lepidopteran Pheromones (aldehydes and alcohols) in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 (OJ L 191, 20.7.2022, p. 35).
(8) Commission Regulation (EU) 2023/466 of 3 March 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, novaluron and tetraconazole in or on certain products (OJ L 68, 6.3.2023, p. 55).
ANNEX
Regulation (EC) No 396/2005 is amended as follows:
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(1) |
in Annex II, the columns for isoxaben, metaldehyde and paclobutrazol are replaced by the following: ‘ANNEX II Pesticide residues and maximum residue levels (mg/kg)
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(2) |
in Annex IV, the following entries are inserted in alphabetical order: ‘Metarhizium brunneum strain Ma 43’, ‘Straight Chain Lepidopteran Pheromones (SCLP)’. |
(*1) Indicates lower limit of analytical determination
(1) For the complete list of products of plant and animal origin to which MRL's apply, reference should be made to Annex I